With respect to humans and appetite suppression or weight control, a wide variety of low-calorie foods, dietary supplements, pharmaceuticals, medical foods, functional foods and nutraceutical agents have been suggested. Additionally, a number of dietary weight loss and weight control programs have been suggested, many of which incorporate the use of dietary supplements or therapeutic agents. Known therapeutic agents (e.g., as drugs) and known dietary supplements act by a variety of mechanisms. Exemplary drugs include epinephrine (as a pure substance, or in the form within the ephedra herb), norepinephrine, 5-hydroxytryptamine (e.g., flenfluramine), phenylpropanolamine, phentermine, and various amphetamines. The active agents within those drugs have been demonstrated to have some degree of efficacy, but are subject to disadvantages. For example, phenteramine has potential side-effects like nervousness, insomnia, and constipation. Moreover, patients generally develop a tolerance to the drug, and certain programs lasting longer than about eight weeks often are not desirable or feasible. Fenfluramine has been associated with primary pulmonary hypertension (PPH), a deadly disorder in which the blood vessels of the lungs are destroyed. There also has been an interest in investigating dietary supplements and active ingredients that are derived from natural sources. See, for example, U.S. Pat. No. 6,224,873 to Jones.
A natural material that has been associated with altering appetite in animals is derived from portions of the jojoba plant. The jojoba plant, Simmondsia californica or S. chinenese, is an evergreen shrub that grows wild in Arizona, lower California, and western Mexico. Recently jojoba has been grown, planted, and cultivated as a domestic crop. Typically, the jojoba plant is cultivated for its seeds from which a wax ester oil is removed. The resultant oil is used in cosmetic formulations and lubricant formulations. Portions of the jojoba plant also are used as a feedstock for livestock. See, for example, Elliger et al., J. Chem. Soc. Perkin Trans. I 2209-2212 (1973).
Jojoba meal has a high content of simmondsin compounds, and in particular, simmondsin (I), simmondsin-2′-ferulate (II), and related cyanomethylenecyclohexyl glycosides (Elliger et al., Phytochemistry 13, 2319 (1974) and Manos et al., J. Agric. Food Chem. 34, 801-805 (1986)). Simmondsin compounds have been demonstrated to alter appetite in rats (Flo et al., Appetite, 34 147-151 (2000), Cokelaere et al., Food Chem. Toxicol. 36, 13-19 (1998), Cokelaere et al., Ind. Crops Prod, 4 91-96 (1995), Cokelaere et al., Horm. Metab. Res., 318-321 (1995), Cokelaere et al., J. Agric. Food Chem. 41, 1449-1451 (1993), Cokelaere et al., J. Agric. Food Chem. 40, 2443-2445 (1992), Cokelaere et al., J. Agric. Food Chem. 40, 1839-1842 (1992), Cokelaere et al., J. Agric. Food Chem. 41, 1444-1448 (1993), and Booth et al., Life Sciences 15(6), 1115-1120 (1974)); mice (Verbiscar et al., J. Agric. Food Chem. 28, 571-578 (1980)); chickens (Arnouts et al., Poultry Science 72, 1714-1721 (1993); and domestic cats and dogs (U.S. Pat. No. 6,245,364 to Jones et al and U.S. Pat. No. 5,962,043 to Jones et al).
Various techniques for separating simmondsins compounds from jojoba meal have been suggested. See, for example, Medina et al., Cereal Chem. 67(5) 476-479 (1990), Verbiscar et al., J. Agric. Food Chem. 29, 296-302 (1981), Verbiscar et al., J. Agric. Food Chem. 28, 571-578 (1980) and Booth et al., Life Sciences 15(6), 1115-1120 (1974). Furthermore, U.S. Pat. No. 6,007,823 to Abbott et al. proposes a method for isolation of simmondsin compounds. Typically, simmondsin compounds are first extracted from defatted jojoba meal using water. After separation, the water extract is isolated and water removed to provide the simmondsin compounds as a solid extract. Individual simmondsin compounds are isolated from the dried extract by contact with a first ethanolic solvent forming a first solvent fraction. The first solvent fraction is then separated from the solid phase and the ethanolic solvent removed by drying. See, also, U.S. Pat. No. 5,672,371 to d'Oosterlynck.
It would be desirable to provide a composition derived from a natural source (e.g., a jojoba extract containing at least one simmondsin compound), in a form to be administered as a beneficial or therapeutic composition for the purpose of controlling the intake of food in humans. Such controlled intake of food can be used as part of a treatment program for various eating disorders and related conditions (e.g., obesity).